Cell, gene, and tissue therapies are revolutionizing modern healthcare, holding the promise to treat and even cure a spectrum of previously intractable conditions. USP is leading the charge to establish cutting edge standards in the cell and gene therapy arena, ensuring these novel therapies meet the highest quality, safety, and efficacy benchmarks. Working with industry frontrunners, medical experts, and regulators, USP is streamlining the transition of cell and gene therapies from ground-breaking research to mainstream clinical practice, making advanced treatments both effective and widely available. As the realm of cell and gene therapies expands, USP continues to lay the groundwork necessary for their quality product development, validation, and integration into global healthcare systems.
USP Monographs
- Octoxynol 9
- Reference Standard: USP Nonoxynol 9 RS
- Reference Standard: USP Octoxynol 9 RS
- L-Alanyl-L-glutamine
- Reference Standard: USP Glutamine RS
- Reference Standard: USP l-Alanine RS
- Reference Standard: USP l-Alanyl-l-alanine RS
- Reference Standard: USP l-Alanyl-l-glutamine RS
- Glutamine
- Reference Standard: USP Glutamine RS
- Poloxamer
- Reference Standard: USP Poloxamer Liquid RS
- Reference Standard: USP Poloxamer Solid RS
- Dextrose
- Reference Standard: USP Dextrose RS
- Reference Standard: USP Fructose RS
- Reference Standard: USP Maltose Monohydrate RS
- Reference Standard: USP Maltotriose RS
- Dextrose excipient
- Reference Standard: USP Dextrose RS
- Reference Standard: USP Fructose RS
- Reference Standard: USP Maltose Monohydrate RS
- Reference Standard: USP Maltotriose RS
- Magnesium Chloride
- Reference Standard: USP Magnesium Chloride RS
- Dimethyl Sulfoxide
- Reference Standard: USP Dimethyl Sulfoxide RS
USP-NF Chapters
- 〈61〉 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- 〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- 〈63〉 Mycoplasma Tests
- 〈71〉 Sterility Tests
- 〈85〉 Bacterial Endotoxins Test
- Reference Standard: USP Endotoxin RS
- 〈89〉 Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
- Reference Standard: USP Trypsin Recombinant Porcine RS
- 〈507〉 Protein Determination Procedures
- Reference Standard: USP BSA for Protein Quantitation RS
- 〈509〉 Residual DNA Testing
- Reference Standard: USP CHO Genomic DNA RS
- Reference Standard: USP E. coli Genomic DNA RS
- Analytical Reference Material: Quantitative HEK-293 Genomic DNA
- Analytical Reference Material: Quantitative Sf9 Genomic DNA
- 〈785〉 Osmolality and Osmolarity
- 〈788〉 Particulate Matter in Injections
- Reference Standard: USP Particle Count RS
- 〈789〉 Particulate Matter in Ophthalmic Solutions
- 〈790〉 Visible Particulates in Injections
- 〈791〉 pH
- 〈1040〉 Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies
- 〈1042〉 Cell Banking Practices for Recombinant Biologics
- 〈1043〉 Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- 〈1044〉 Cryopreservation of Cells
- 〈1047〉 Gene Therapy Products
- 〈1050〉 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
- 〈1071〉 Rapid Sterility Testing of Short Life Products A Risk Based Approach
- 〈1085〉 Guidelines on the Endotoxins Test
- 〈1103〉 Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
- 〈1104〉 Immunological Test Methods—Immunoblot Analysis
- 〈1125〉 Nucleic Acid-Based Techniques—General
- 〈1126〉 Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing
- 〈1127〉 Nucleic Acid-Based Techniques—Amplification
- 〈1128〉 Nucleic Acid-Based Techniques—Microarray
- 〈1130〉 Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
- 〈1132〉 Residual Host Cell Protein Measurement in Biopharmaceuticals
- 〈1430.3〉 Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering
- 〈1776〉 Image Analysis of Pharmaceutical Systems
- 〈1787〉 Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
- 〈1788.3〉 Flow Imaging Method for the Determination of Subvisible Particulate Matter
- 〈1790〉 Visual Inspection of Injections
USP Monographs
- Chymotrypsin
- Reference Standard: USP Chymotrypsin RS
- Reference Standard: USP Trypsin Bovine RS
- Insulin Human
- Reference Standard: USP Insulin Human RS
- Trypsin
- Reference Standard: USP Trypsin Bovine RS
- Reference Standard: USP Trypsin Recombinant Porcine RS
- Construct Human Fibroblasts in Polyglactin Scaffold
- Reference Standard: USP Authentic Visual References RS
- Reference Standard: USP Construct Human Fibroblasts in Polyglactin Scaffold Reference Photomicrographs
- Tissue Human Amnion Chorion Membrane Dehydrated
- Construct Human Fibroblasts in Bilayer Synthetic Scaffold
- Reference Standard: USP Authentic Visual References RS
- Construct Human Fibroblasts in Polyglactin Scaffold
- Reference Standard: USP Authentic Visual References RS
- Reference Standard: USP Construct Human Fibroblasts in Polyglactin Scaffold Reference Photomicrographs
- Scaffold Porcine Small Intestinal Submucosa
- Reference Standard: USP Authentic Visual References RS
- Reference Standard: USP Cultured Rat Pheochromocytoma Reference Photomicrographs
- Construct Human Keratinocytes and Fibroblasts in Bovine Collagen Scaffold
- Reference Standard: USP Authentic Visual References RS
- Scaffold Bovine Dermis
- Reference Standard: USP Authentic Visual References RS
- Scaffold Human Dermis
- Reference Standard: USP Authentic Visual References RS
- Scaffold Human Amniotic Membrane Allograft
- Scaffold Porcine Bladder
- Sipuleucel-T
- Scaffold Silk Fibroin
USP-NF Chapters
- 〈61〉 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- 〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- 〈63〉 Mycoplasma Tests
- 〈71〉 Sterility Tests
- 〈85〉 Bacterial Endotoxins Test
- Reference Standard: USP Endotoxin RS
- 〈87〉 Biological Reactivity Tests, In Vitro
- Reference Standard: USP High-Density Polyethylene RS
- 〈88〉 Biological Reactivity Tests, In Vivo
- Reference Standard: USP High-Density Polyethylene RS
- 〈89〉 Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
- Reference Standard: USP Trypsin Recombinant Porcine RS
- 〈89.1〉 Collagenase I
- Reference Standard: USP Collagenase I RS
- 〈89.2〉 Collagenase II
- Reference Standard: USP Collagenase II RS
- 〈90〉 Fetal Bovine Serum—Quality Attributes and Functionality Tests
- Reference Standard: USP Fetal Bovine Serum RS
- 〈92〉 Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Reference Standard: USP rHuman Interleukin 4 RS
- 〈127〉 Flow Cytometric Enumeration of CD34+ Cells
- Reference Standard: USP CD34+ Cell Enumeration System Suitability
- 〈507〉 Protein Determination Procedures
- Reference Standard: USP BSA for Protein Quantitation RS
- 〈785〉Osmolality and Osmolarity
- 〈788〉 Particulate Matter in Injections
- Reference Standard: USP Particle Count RS
- 〈789〉 Particulate Matter in Ophthalmic Solutions
- 〈790〉 Visible Particulates in Injections
- 〈791〉 pH
- 〈1024〉 Bovine Serum
- 〈1027〉 Flow Cytometry
- 〈1042〉 Cell Banking Practices for Recombinant Biologics
- 〈1043〉 Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- 〈1044〉 Cryopreservation of Cells
- 〈1046〉 Cell-Based Advanced Therapies and Tissue-Based Products
- 〈1049〉 Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
- 〈1050〉 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
- 〈1071〉 Rapid Sterility Testing of Short Life Products A Risk Based Approach
- 〈1085〉 Guidelines on the Endotoxins Test
- 〈1103〉 Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
- 〈1104〉 Immunological Test Methods—Immunoblot Analysis
- 〈1125〉 Nucleic Acid-Based Techniques—General
- 〈1126〉 Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing
- 〈1127〉 Nucleic Acid-Based Techniques—Amplification
- 〈1128〉 Nucleic Acid-Based Techniques—Microarray
- 〈1130〉 Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
- 〈1132〉 Residual Host Cell Protein Measurement in Biopharmaceuticals
- 〈1285〉 Preparation of Biological Specimens for Histologic and Immunohistochemical Analysis
- 〈1285.1〉 Hematoxylin and Eosin Staining of Sectioned Tissue for Microscopic Examination
- 〈1430.3〉 Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering
- 〈1776〉 Image Analysis of Pharmaceutical Systems
- 〈1787〉 Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
- 〈1788.3〉 Flow Imaging Method for the Determination of Subvisible Particulate Matter
- 〈1790〉 Visual Inspection of Injections
USP Monographs
- Octoxynol 9
- Reference Standard: USP Nonoxynol 9 RS
- Reference Standard: USP Octoxynol 9 RS
- L-Alanyl-L-glutamine
- Reference Standard: USP Glutamine RS
- Reference Standard: USP l-Alanine RS
- Reference Standard: USP l-Alanyl-l-alanine RS
- Reference Standard: USP l-Alanyl-l-glutamine RS
- Glutamine
- Reference Standard: USP Glutamine RS
- Poloxamer
- Reference Standard: USP Poloxamer Liquid RS
- Reference Standard: USP Poloxamer Solid RS
- Dextrose
- Reference Standard: USP Dextrose RS
- Reference Standard: USP Fructose RS
- Reference Standard: USP Maltose Monohydrate RS
- Reference Standard: USP Maltotriose RS
- Dextrose excipient
- Reference Standard: USP Dextrose RS
- Reference Standard: USP Fructose RS
- Reference Standard: USP Maltose Monohydrate RS
- Reference Standard: USP Maltotriose RS
- Magnesium Chloride
- Reference Standard: USP Magnesium Chloride RS
- Dimethyl Sulfoxide
- Reference Standard: USP Dimethyl Sulfoxide RS
USP-NF Chapters
- 〈61〉 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- 〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- 〈63〉 Mycoplasma Tests
- 〈71〉 Sterility Tests
- 〈85〉 Bacterial Endotoxins Test
- Reference Standard: USP Endotoxin RS
- 〈87〉 Biological Reactivity Tests, In Vitro
- Reference Standard: USP High-Density Polyethylene RS
- 〈88〉 Biological Reactivity Tests, In Vivo
- Reference Standard: USP High-Density Polyethylene RS
- 〈89〉 Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
- Reference Standard: USP Trypsin Recombinant Porcine RS
- 〈507〉 Protein Determination Procedures
- Reference Standard: USP BSA for Protein Quantitation RS
- 〈509〉 Residual DNA Testing
- Reference Standard: USP CHO Genomic DNA RS
- Reference Standard: USP E. coli Genomic DNA RS
- Analytical Reference Material: Quantitative HEK-293 Genomic DNA
- 〈785〉 Osmolality and Osmolarity
- 〈788〉 Particulate Matter in Injections
- Reference Standard: USP Particle Count RS
- 〈789〉 Particulate Matter in Ophthalmic Solutions
- 〈790〉 Visible Particulates in Injections
- 〈791〉 pH
- 〈1027〉 Flow Cytometry
- 〈1040〉 Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies
- 〈1042〉 Cell Banking Practices for Recombinant Biologics
- 〈1043〉 Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- 〈1044〉 Cryopreservation of Cells
- 〈1047〉 Gene Therapy Products
- 〈1050〉 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
- 〈1071〉 Rapid Sterility Testing of Short Life Products A Risk Based Approach
- 〈1085〉 Guidelines on the Endotoxins Test
- 〈1103〉 Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
- 〈1104〉 Immunological Test Methods—Immunoblot Analysis
- 〈1125〉 Nucleic Acid-Based Techniques—General
- 〈1126〉 Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing
- 〈1127〉 Nucleic Acid-Based Techniques—Amplification
- 〈1128〉 Nucleic Acid-Based Techniques—Microarray
- 〈1130〉 Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
- 〈1132〉 Residual Host Cell Protein Measurement in Biopharmaceuticals
- 〈1430.3〉 Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering
- 〈1776〉 Image Analysis of Pharmaceutical Systems
- 〈1787〉 Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
- 〈1788.3〉 Flow Imaging Method for the Determination of Subvisible Particulate Matter
- 〈1790〉 Visual Inspection of Injections
Spotlight
Cell & Gene Therapy Insights
Application Note
DNA Phosphoramidite Reference Standards
USP hosts Stakeholder Forum on Innovative Analytical Approaches to Cell & Gene Therapy
USP and ATCC deliver Webinar on Residual DNA Testing Solutions
Products & Resources
Publications
- Overcoming challenges in gene therapy analytics
- What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production
- Solving Bioassay Challenges for Cell & Gene Therapies
- Overcoming Challenges to CAR-T Cell Therapies in India
- Advanced Therapies: Industry & Regulatory Members Share Perspectives at NIFDS-USP Joint Workshop
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Education
- Viral Vector Manufacturing and Control Strategies
- Quality Considerations for Plasmid DNA as a Starting Material for Cell and Gene Therapies
- USP Standards and Best Practices for Gene Therapy
- What’s New in Biologics? Standards to Support Advanced Therapies
- Opportunities and Challenges in Raw Material and Starting Material Qualification for Cell and Gene Therapy Products
- Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
- Application Note: DNA Phosphoramidite Reference Standards
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